Acamprosate in Alcoholics With Comorbid Anxiety or Depression

• ClinicalTrials.gov Identifier: NCT00330174
• Recruitment Status: Completed
• First Posted: May 26, 2006
• Results First Posted: April 13, 2015
• Last Update Posted: April 13, 2015
• Sponsor: Medical University of South Carolina
• Collaborators: Mclean Hospital; Columbia University
• Information provided by (Responsible Party): Susan Sonne, Medical University of South Carolina

Study Description

Brief Summary:

STUDY OBJECTIVES:

The primary objective of this study is to compare the safety and efficacy of acamprosate versus placebo in the treatment of alcohol dependence in adults with co-occurring mood or anxiety disorders (specifically, depression (MDE), generalized anxiety disorder (GAD) or social anxiety disorder). Secondary objectives are to evaluate the effect of acamprosate treatment on mood and anxiety disorders.

STUDY DESIGN:

This is a randomized, double-blind, placebo-controlled trial evaluating acamprosate in the treatment of alcohol dependence in adult outpatients with concurrent mood and/or anxiety disorders. The active study phase will be 12 weeks in duration. There will be a two-week screening period, followed by 12 weeks of study medication and a follow-up assessment at 14 weeks from randomization.

STUDY POPULATION:

A total of 90 (30 per site) men and women aged 18-60 years who have a current diagnosis of alcohol dependence as well as a current DSM-IV diagnosis of either MDE, GAD and/or social anxiety will be recruited to participate in this study. Only those individuals whose psychiatric disorders are stable will be randomized to acamprosate or placebo. Three sites will participate in this trial.

TREATMENTS:

Eligible participants will be randomly assigned to receive either acamprosate or matching placebo for 12 weeks.

EFFICACY ASSESSEMENTS:

The primary efficacy outcome measure will be cumulative days abstinent as measured by self-report.

Condition or disease	Intervention/treatment	Phase
Alcohol Dependence; Major Depression; Social Anxiety Disorder; Generalized Anxiety Disorder	Drug: Acamprosate	Phase 4

Detailed Description:

Participants who meet all inclusion criteria and none of the exclusion criteria will be randomized to receive either acamprosate or placebo in a 1:1 ratio. Participants will be instructed to take (2) 333 mg tablets three times a day. Participants will be seen weekly for 12 weeks an again 14 weeks from randomization. At each weekly visit, participants will be asked about substance use and possible adverse events. They will also have their vital signs and weight measured at each visit. Psychiatric assessments, including the MADRS,HAM-A, Liebowitz Social Anxiety Scale, and Hospital Anxiety and Depression Scale will be performed at weeks 2, 4, 8, and 12. Alcohol craving will be assessed using the Obsessive Compulsive Drinking Scale at baseline and monthly. A urine drug screen will also be performed monthly. A clinical global impressions scale will be completed for both psychiatric and alcohol abuse symptoms at every visit. A breath alcohol test will be performed at every visit, and a urine drug screen will be performed at baseline and monthly during the trial.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Use of Acamprosate in Individuals With Alcohol Dependence and Comorbid Anxiety or Depression
• Study Start Date: April 2006
• Actual Primary Completion Date: September 2010
• Actual Study Completion Date: September 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Acamprosate tablets	Drug: Acamprosate; 2 333mg tablets three times daily
Placebo Comparator: 2; Matching placebo tablets	Drug: Acamprosate; 2 333mg tablets three times daily

Outcome Measures

Primary Outcome Measures :

1. Percent Days Drinking [ Time Frame: 12 weeks ]
   Drinking was assessed using the timeline followback (TLFB), which is a calendar-based instrument used to assess drinking and other substance use on a daily basis.

Secondary Outcome Measures :

1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]
   This 10-item rating scale is commonly used in the European pharmacotherapy trials, and it may have benefit in assessing substance abusers, because it focuses on cognitive symptoms of depression instead of the physical symptoms, which could be due to substance use and withdrawal (Yonkers and Samson, 2000). Total scores are used; Scale range is 0-60, with higher scores reflecting more severe symptoms.
2. Liebowitz Social Anxiety Scale [ Time Frame: 12 weeks ]
   The LSAS is a 24-item semi-structured clinician-administered instrument that assesses social anxiety through the evaluation of fear and avoidance of different social and performance situations. There are two subscales (avoidance and fear), with scores ranging from 0-72; Total score for instrument ranges from 0-144. This study only reports on total score. Higher scores reflect greater anxiety symptoms.
3. Hospital Anxiety and Depression Scale [ Time Frame: 12 weeks ]
   This is a 14-item self report assessment that contains two subscales (depression and anxiety) with each subscale ranging from 0-21; the total score ranges from 0-42. We report total scores. Higher scores represent worse symptoms.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Adults ages 18-60
2. Meet DSM-IV criteria for current (past 90 days) alcohol dependence
3. Must identify alcohol as the primary substance of abuse
4. Meet DSM-IV criteria for a current major depressive episode, GAD and/or social anxiety disorder
5. Have a stable psychiatric condition, as evidenced by a baseline CGI change score of 4 or below between the time of initial screening and the baseline visit, and if receiving psychotropic medication, must have a stable dose of medication for at least one month prior to baseline.
6. Must have a negative urine drug screen at the baseline visit; UDS may be repeated no more that twice to obtain an negative UDS
7. May be receiving medication treatment for anxiety/mood disorder as long as the dosage has been stable for 4 weeks prior to randomization.
8. May be engaged in psychosocial treatment for alcohol dependence or for mood/anxiety disorders.
9. Must abstain from alcohol for at least 3 consecutive days but no more than 21 days prior to medication initiation
10. Subjects must be able to adequately provide informed consent and function at an intellectual level sufficient to allow the accurate completion of all assessment instruments
11. Subjects must consent to random assignment, be willing to commit to medication treatment and follow-up assessments
12. CIWA-Ar scale is 8 or less at the baseline visit

Exclusion Criteria:

1. Individuals with a primary psychotic disorder or bipolar disorder
2. Individuals who meet DSM-IV criteria for current (past 90 days) dependence on substances other than alcohol, caffeine or nicotine
3. Individuals with an uncontrolled neurologic condition that could confound the results of the study
4. Individuals with an uncontrolled medical condition that may adversely affect the conduct of this trial or jeopardize the subject's safety
5. Regular use of benzodiazepines for the treatment of psychiatric symptoms (as defined as more than 12 times in the month prior to the screening visit)
6. Individuals receiving pharmacotherapy (e.g. disulfiram or naltrexone) for prevention of alcohol relapse
7. Women of childbearing potential who are lactating or refuse to use adequate forms of birth control
8. Current suicidal or homicidal risk

Contacts and Locations

Locations

United States, Massachusetts

McLean Hospital

Belmont, Massachusetts, United States, 02478

United States, New York

Columbia University College of Physicians & Surgeons

New York, New York, United States, 10025

United States, South Carolina

Behavioral Health Services of Pickens County

Pickens, South Carolina, United States, 29671

Sponsors and Collaborators

Medical University of South Carolina

Mclean Hospital

Columbia University

Investigators

• Principal Investigator: Susan C Sonne, PharmD, BCPP; Medical University of South Carolina
• Principal Investigator: Jennifer S Potter, PhD; Mclean Hospital
• Principal Investigator: Richard Rosenthal, MD; Columbia University College of Physicians & Surgeons

More Information

• Responsible Party: Susan Sonne, Associate Professor of Psychiatry, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT00330174
• Other Study ID Numbers: CMP-MD-04
• First Posted: May 26, 2006
• Results First Posted: April 13, 2015
• Last Update Posted: April 13, 2015
• Last Verified: April 2015

Keywords provided by Susan Sonne, Medical University of South Carolina:

Alcoholism; Mood; Anxiety; Acamprosate

Additional relevant MeSH terms:

Disease; Alcoholism; Depression; Depressive Disorder; Anxiety Disorders; Phobia, Social; Pathologic Processes; Behavioral Symptoms; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Phobic Disorders; Acamprosate; Alcohol Deterrents